YY/T 1789.2-2021 Active Industry standards-Medicine

YY/T 1789.2-2021 In vitro diagnostic test systems—Performance evaluation method—Part 2:Trueness

Publish Date: 2021-12-06 Implement Date: 2023-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1789.2-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Laboratory medicine

Publish Date: 2021-12-06

Implement Date: 2023-05-01

Pages: 24 pages

Scope

This part of YY/T 1789 specifies the evaluation method for the accuracy performance of in vitro diagnostic testing systems.
This part is applicable to manufacturers conducting accuracy evaluations of in vitro diagnostic testing systems for quantitative testing.
This part is not applicable to in vitro diagnostic testing systems whose results are reported using nominal or ordinal scales, such as those used for blood cell identification, microbial typing, nucleic acid sequence identification, and urine particle identification, where the results are reported as negative, positive, or 1+, 2+, 3+. This part is also not applicable to the evaluation of the performance of qualitative in vitro diagnostic testing systems based on quantitative measurements and judgment of results by thresholds (for example, enzyme-linked immunosorbent assay kits for the detection of pathogenic microorganism antigens or antibodies).
This part is not applicable to accuracy performance verification in medical laboratories, nor to product type testing.